Type 1 Diabetes
Conditions
Keywords
Diabetes Type 1, Diabetes, Insulin-Dependent, Liraglutide, Preclinical Type 1 Diabetes, GLP-1 Analogue, Dysglycemia, Prevention
Brief summary
The objective of the trial is to study whether daily treatment with liraglutide improves endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet autoantibodies and have dysglycemia.
Interventions
DRUGVictoza®
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
DRUGPlacebo
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
Sponsors
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
Skane University Hospital
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* 10-30 years of age * positive for at least 2 islet autoantibodies * glucose intolerance or dysglycemia: impaired glucose tolerance (IGT, 2-hour p-gluc 7.8-11.0mmol/l), or impaired fasting glucose (IFG, fp-gluc 6.1-6.9mmol/l), and/or 10% rise in HbA1c since the last measurement (2 - 12 mo ago), and/or p-gluc at least 11.1mmol/l at 30, 60 or 90 min during OGTT * not pregnant
Exclusion criteria
* allergic to liraglutide or other ingredients of Victoza * type 1 diabetes * diabetic ketoacidosis * previous treatment in the last three months with any antidiabetic medication * impaired liver or kidney function or on dialysis * severe heart failure * severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease * past or current history of pancreatitis * serum calcitonin value above normal (\>50 ng/l or at least 3.4pmol/l) * presence of any chronic metabolic, hematologic or malignant disease * obesity BMI at least 30 * pregnant females and females of childbearing potential who are not using adequate contraceptive methods. * breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FPIR (1+3min serum insulin level after iv glucose infusion) | 12 months | First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia | 12 months | Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia |
| Tolerability | 12 months | Tolerability: frequency of side effects, hypoglycaemia and gastrointestinal symptoms in particular |
| Serum C-peptide AUC | 12 months | Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test) |
Countries
Finland, Sweden
Outcome results
None listed